LightLab Imaging Announces FDA Clearance of C7-XR(TM) Coronary OCT Products in the United States

Press releases may be edited for formatting or style | May 06, 2010

"LightLab has been delivering state-of-the art intracoronary OCT systems to leading hospitals outside of the United States for over 5 years," said David Kolstad, CEO of LightLab Imaging. "With our clearance by the FDA, U.S. clinicians now have access to a fast and easy-to-use, high-resolution imaging system. We believe C7-XR Imaging System and C7 Dragonfly Imaging Catheter will enhance the diagnostic information and procedural control available to U.S. clinicians. We will begin offering the C7-XR Imaging System and the C7 Dragonfly Imaging Catheter immediately."

LightLab Imaging will demonstrate the C7-XR Imaging System and C7 Dragonfly Imaging Catheter in booth number 28 at the Society for Cardiovascular Angiography and Interventions' 2010 Scientific Sessions in San Diego, from May 5 to 8.

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LightLab's U.S. clinical study of the C7-XR Imaging System and C7 Dragonfly Imaging Catheter was conducted at three U.S. centers. The centers and the investigators were:

* Massachusetts General Hospital: Ik-Kyung Jang, M.D., Ph.D.
* Columbia University Presbyterian Hospital: Jeffrey Moses, M.D., FACC, Giora Weisz, M.D., George Dangas M.D., Ph.D., and Varinder Singh, M.D.
* Stanford University Medical Center: William Fearon, M.D. and Alan Yeung, M.D.

The core laboratory responsible for analyzing the study results was:

* University Hospitals Case Medical Center-Interventional Cardiovascular Center and Research & Innovation Center: Marco Costa M.D., Ph.D. and Hiram G. Bezerra, M.D., Ph.D.

About LightLab Imaging, Inc.

LightLab Imaging, Inc., based in Westford MA, is the world's leading manufacturer and marketer of Optical Coherence Tomography (OCT) for vascular and other imaging applications. LightLab's OCT systems and imaging catheters are cleared for sale in 40 countries in Europe, Asia, the Middle East and North and South America. The company was founded in 1998 by the inventors of OCT, and has exclusive license to a broad range of OCT technologies and applications from MIT and other entities. The LightLab mission is to develop and distribute photonic imaging technologies that improve patients' wellbeing, enhance diagnostic medicine, improve outcomes, and reduce healthcare expenditures. With the ability to resolve real-time images to 15 micrometers, the LightLab Imaging OCT Imaging Systems offer physicians more precise information than ever before. For more information, visit www.lightlabimaging.com.

About LightLab OCT

LightLab Optical Coherence Tomography (OCT) is the Extreme Resolution™ imaging technology for cardiovascular disease diagnosis. LightLab OCT utilizes near-infrared light to create images with 10 times the resolution of Intravascular ultrasound (IVUS). LightLab OCT is a radiation-free* imaging system.